Cranial remodeling is utilized to correct for deformities in the head shapes of infants. Prior to the development of the Dynamic Orthotic CranioplastySM method of cranial remodeling by Cranial Technologies, Inc, the assignee of the present invention, the only viable approach for correction of cranial deformities was surgical correction of the shape of the cranium. Dynamic Orthotic CranioplastySM utilizes a treatment protocol in which the DOC BAND® cranial remodeling device is custom produced for each subject to be treated.
In the past, custom cranial remodeling devices were produced by first obtaining a full size and accurate cast of the actual head shape of each subject. This cast was then modified to produce a second or desired head shape model. The second or desired head shape model is used to form the cranial remodeling band for the infant. In the past, the second or desired shaped head shape model was obtained by manually modifying the first cast to form the desired shape model.
Cranial Technologies has maintained a “library” of the casts of the head casts of infant's deformed heads and the corresponding models of the desired corrected head shapes.
Cranial Technologies, Inc. continued its pioneering developments with its proprietary DSI® digital image capturing system and its Digital Surface Imaging® methodology for the time efficient and safe image capture of three-dimensional full head images.
More specifically, the DSI® digital image capturing system was utilized to capture DSI® digital data representative of digital images of each cast of a deformed head and each corresponding model of the corrected head shape and store the DSI® digital data for each digital image in first and second databases, respectively. The first and second databases were utilized to train a neural network.
Cranial Technologies developed a system that utilized these first and second databases to automatically produces digital data representative of a modified head shape from DSI® digital data representative of a deformed head. A processor is trained to operate on a new set of captured data for a first head shape to produce a corresponding modified head shape.
An improved Cranial Technologies system utilizes a first database comprising captured DSI® digital data representative of a deformed head captured directly from the subject and it is that digital data that is processed to generate data representative of the deformed head.
The systems developed by Cranial Technologies require manipulation of the captured data for a variety of reasons.
The captured data file of each subject is reoriented to a predetermined orientation. In addition, a portion of the DSI® image data file is selected for further use and portions that will not be utilized are eliminated.
The DSI® digital image capturing system and its Digital Surface Imaging® have proven to be highly effective and has set the standard for three-dimensional image capture. In capturing images of infant subjects, an adult typically holds the infant in an upright-seated position. The hands of the adult are placed on the infant on the chest and back of the infant to support the infant in an upright position. Because of the variation in sizes of the infants, the field of capture is selected such that the three-dimensional image typically includes at least the shoulder and chest of the infant and accordingly, the three-dimensional image includes the hands and sometimes the wrist and a portion of the adult supporting the infant in position.
However, it is only the head of the subject infant that is of significance in the manufacture of the corrective cranial remodeling device. The remainder of the digital three-dimensional image captured including the supporting hands is of no interest and the three-dimensional image processing must remove that portion of the image that is of no interest.